Pelvic Floor Shear-Wave Elastography in Healthy and Pudendal Neuralgia Women (ELANEP)

Comparison of Superficial Pelvic Floor Shear Wave Elastography Between Healthy Women and Women With Pudendal Neuralgia

This study will compare superficial pelvic floor shear-wave elastography between healthy women and women with pudendal neuralgia.

Study Overview

• Status: Completed
• Conditions: Healthy Women; Pudendal Nerve
• Intervention / Treatment: Diagnostic test: Pelvic floor shear wave elastography; Diagnostic test: Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7); Diagnostic test: Female Sexual Distress Scale-Revised (FSDS-R)

Detailed Description

Using shear-wave elastography, this study will compare the superficial pelvic floor muscles (bulbospongiosus, ischiocavernosus, and superficial transverse perineal muscles) between healthy women and women with pudendal neuralgia.

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Slovakia
  • Slovakia
    • Martin, Slovakia, Slovakia, 040 22
      • Comenius University in Bratislava, Jessenius Faculty of Medicine , Martin, Slovakia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Study Population This observational study enrolled adult women (≥18 years) categorized into two cohorts: a pudendal neuralgia (PN) group and a healthy control group.

Participants in the PN group were recruited from an outpatient clinic database. Inclusion required a diagnosis of pudendal neuralgia confirmed by a gynecologist according to the Nantes criteria (Labat et al., 2008), including a positive response to an anesthetic pudendal nerve block, and a symptom duration of ≥ 3 months.

The healthy control group consisted of volunteers recruited from university staff with no history of chronic pelvic pain or pelvic floor dysfunction.

Description

Inclusion Criteria (Pudendal Neuralgia Group)

Diagnosis of Pudendal Neuralgia based on the Nantes diagnostic criteria (Labat et al., 2008), specifically:

• Pain located in the anatomical territory of the pudendal nerve.
• Pain worsened by sitting.
• Pain that does not wake the patient at night.
• No objective sensory loss on clinical examination.
• Positive response to an anesthetic pudendal nerve block.
• Duration of symptoms: Chronic pelvic pain persisting for more than 3 months.
• Demographics: Women aged (≥18 years).
• Voluntary participation: Ability to understand and sign informed consent.

Inclusion Criteria (Healthy Controls)

• Demographics: Women aged (≥18 years).
• Asymptomatic status: No history or current symptoms of chronic pelvic pain or pelvic floor dysfunction (confirmed by clinical interview/screening).
• Voluntary participation: Signed informed consent.

Exclusion Criteria (Both Groups)

• Medical Comorbidities: Diagnosed psychiatric, neurological (other than PN), severe internal, orthopedic, or oncological diseases that could interfere with the study outcomes.
• Recent Interventions: History of botulinum toxin therapy to the pelvic floor within the last 12 months.
• Pelvic surgery within the last 12 months.
• Data Integrity: Incomplete or incorrectly filled questionnaires.
• General: Unwillingness to participate or inability to provide informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with Pudendal Neuralgia; Adult women (≥18 years) with chronic pelvic pain consistent with pudendal neuralgia . The diagnosis of pudendal neuralgia was confirmed by a gynecologist.	Diagnostic test: Pelvic floor shear wave elastography; Imaging was performed using a Consona N8 ultrasound system (Shenzhen Mindray Bio-Medical Electronics Co., Ltd.) equipped with shear-wave elastography (SWE) software. A linear-array transducer (L13-3N; frequency range 3.0-13.0 MHz; field of view ~3.8-4.0 cm) was used to obtain pelvic floor muscle (PFM) images. Measurements were performed using shell analysis by comparing two locations within the same pelvic floor muscle: the sites with the highest and lowest stiffness (kPa).; Diagnostic test: Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7); The PFIQ-7 is a 21-item questionnaire (three scales with seven items each) assessing the impact of pelvic floor disorders on daily life. Items are scored from 0 to 3, and the total score ranges from 0 to 300. Higher scores indicate greater impact/distress.; Diagnostic test: Female Sexual Distress Scale-Revised (FSDS-R); The FSDS-R is a 13-item questionnaire assessing sexually related personal distress in women, with a total score range of 0-52. Items are rated on a 5-point Likert scale (0 = never to 4 = always). Higher scores indicate greater sexual distress.
Healthy women; Healthy women (≥18 years) with no history of chronic pelvic pain or pelvic floor dysfunction.	Diagnostic test: Pelvic floor shear wave elastography; Imaging was performed using a Consona N8 ultrasound system (Shenzhen Mindray Bio-Medical Electronics Co., Ltd.) equipped with shear-wave elastography (SWE) software. A linear-array transducer (L13-3N; frequency range 3.0-13.0 MHz; field of view ~3.8-4.0 cm) was used to obtain pelvic floor muscle (PFM) images. Measurements were performed using shell analysis by comparing two locations within the same pelvic floor muscle: the sites with the highest and lowest stiffness (kPa).; Diagnostic test: Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7); The PFIQ-7 is a 21-item questionnaire (three scales with seven items each) assessing the impact of pelvic floor disorders on daily life. Items are scored from 0 to 3, and the total score ranges from 0 to 300. Higher scores indicate greater impact/distress.; Diagnostic test: Female Sexual Distress Scale-Revised (FSDS-R); The FSDS-R is a 13-item questionnaire assessing sexually related personal distress in women, with a total score range of 0-52. Items are rated on a 5-point Likert scale (0 = never to 4 = always). Higher scores indicate greater sexual distress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography	Stiffness of superficial pelvic floor muscles (bulbospongiosus, ischiocavernosus, superficial transverse perineal muscles) assessed with SWE; comparison between healthy women and women with pudendal neuralgia. Shell analysis was used to identify and compare two specific locations within each muscle: the site of maximum stiffness (b-site) and the site of minimum stiffness (a-site). The data represent the maximum stiffness measured at the most affected sites in KPa. Detailed results for all measured anatomical locations and planes are provided in the full study manuscript.	Baseline (Day 1 after enrollment; single assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Floor Disorder Impact on Quality of Life (PFIQ-7 Total Score and Subscale Scores)	Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) This 21-item instrument assesses the impact of pelvic floor disorders across three domains: bladder (Urinary Impact Questionnaire, UIQ-7), bowel (Colorectal-Anal Impact Questionnaire, CRAIQ-7), and vaginal symptoms. Items are scored from 0 to 3, with total scores ranging from 0 to 300; higher scores indicate a greater negative impact on quality of life .	Baseline (Day 1 after enrollment; single assessment)
Sexual Distress (FSDS-R Total Score)	Female Sexual Distress Scale-Revised (FSDS-R) total score (0-52). Higher scores indicate greater sexual distress.	Baseline (Day 1 after enrollment; single assessment)

Collaborators and Investigators

• Sponsor: Comenius University
• Collaborators: Pavol Jozef Safarik University
• Investigators: Principal Investigator: Magdalena Hagovska, prof.PhDr.PhD., Pavol Jozef Safarik University, Medical Faculty, Kosice Slovakia; Study Director: Jan Svihra, prof.MUDr.PhD., Comenius University Bratislava, Jessenius Faculty of Medicine in Martin, Slovakia

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2025
• Primary Completion (Actual): February 25, 2026
• Study Completion (Actual): March 2, 2026

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pudendal neuralgia, Shear-wave elastography, Healthy women
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Nerve Compression Syndromes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pudendal Neuralgia
• Other Study ID Numbers: 6808/2023/ODDZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No